Regulatory Index News: 12/07/2018

Welcome to your Regulatory Index News digest this Thursday. Including a NICE restriction, a failed trial and positive Phase 3 results.

Restricted use of antibiotics advised by NICE in COPD treatment

Healthcare professionals are being advised by The National Institute for Health and Care Excellence (NICE) to restrict antibiotic use in the treatment of chronic obstructive pulmonary disease (COPD) flare-ups. As acute COPD exacerbations are caused by a number of factors, with only approximately half as a result of bacetrial infections, this advice is given in the hope of helping to reduce anti-microbial resistance. The new clinical guideline from NICE on the diagnosis and management of COPD makes it clear that antibiotics should only be used to prevent flare-ups in patients most likely to benefit from them. COPD is a common, life-threatening illness affecting around 3 million people in the UK (with 2 million undiagnosed) and leads to approximately 115,000 hospital admissions each year. Please click here to read more on this from a PharmaTimes article.

 

Pixuvri late stage trial fails to hit targets in B-cell non-Hodgkin lymphoma

Servier and CTI BioPharma’s post approval commitment to study Pixuvri (pixantrone) in combination with Roche's MabThera (rituximab) has not hit its targets in B-cell non-Hodgkin lymphoma. Despite receiving conditional approval in Europe in 2012 for multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas, this latest outcome in the PIX306 trial puts the drug's future in Europe in doubt. The pixantrone new drug application (NDA) was voluntarily withdrawn in the US in 2012 and not re-submitted since. Please click here to read more on this from a PharmaTimes article.
 

 

Positive Phase 3 Results for anemia drug luspatercept

Celgene announced earlier this week that its investigational blood disorder drug luspatercept met primary and key secondary endpoints of a Phase 3 study evaluating it in patients with transfusion-dependent beta-thalassemia. Results showed that overall, patients receiving the study drug needed fewer red blood cell (RBC) transfusions when compared to those receiving placebo. Investigators observed a 33% reduction from baseline in RBC transfusion burden plus a minimum reduction of two units during the 12 consecutive weeks between week 13 and week 24 of the study. Please click here to read more on this from a BioPharmaDive article.

 

L O

Author

Lorna Osborn

Date Published

12th July 2018

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